The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
Keeping you up to date on recent developments in oncology, including: New study hints that 3D chromatin architecture a key in childhood leukemia; Recruiting NK cells to the antitumor battle; 3D printing meets the medical isotope business.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak.
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
Sen. Amy Klobuchar (D-Minn.) has posted new legislation that would bolster antitrust enforcement and deter anticompetitive behavior in the private sector, but the bill faces considerable opposition. Glenn Lammi of the Washington Legal Foundation told BioWorld that the legislation would blunt investment in the life sciences due to provisions that would make the possession of a patent an indication of legally actionable anticompetitive behavior.
Keeping you up to date on recent developments in oncology, including: Cancer mortality rates falling, but incidence rising among women; Camouflage for better nano-treatments for cervical cancer; Deep learning may boost glial segmentation studies.
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA.
Medical devices are known to be iterative, but so are FDA guidances, and the 2018 draft guidance for third-party review of 510(k) applications was the second such document in two years. The 2020 final guidance made another adjustment or two based on feedback from industry, including a specific note that the intent of the guidance is to eliminate any need for routine FDA re-review of 510(k)s reviewed by third parties.